COMO: Cognition Study With HIV+ Patients (CTNPT 015)

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to contribute evidence towards the potential to improve cognition in HIV+ individuals experiencing cognitive decline through personalized change in antiretroviral (ARV) medication. To that end, following a comprehensive evaluation to identify confounding clinical conditions, study participants will undergo a lumbar puncture to: (i) measure viral load (at 2 copies/ml); (ii) identify Cerebrospinal Fluid (CSF) genotype and tropism; and (iii) measure concentration of antiretroviral agents. When indicated from the CSF analysis, a personalized change in ARV will be implemented. Cognition will be measured in all at study entry and 6 months later.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marie-Josée Brouillette
• Collaborators: CIHR Canadian HIV Trials Network; Fonds de la Recherche en Santé du Québec
• Treatments: Anti-Retroviral Agents

Criteria

Inclusion Criteria:

• are 18 years and older

• have the capacity to give informed consent as determined by the research nurse

• have unexplained cognitive decline (reported either by the patient or an outside informant)

• have been on a stable ART regimen for > 6 months

• have an undetectable viral load in plasma for at least 6 months (a single blip of ≤ 150 copies/mL will be accepted)

• have not had a change in medications that could potentially interfere with cognition in the past 4 months

Exclusion Criteria:

• detectable VL in the plasma

• past history of dementia

• past history of Central Nervous System opportunistic infection or stroke

• current substance abuse ( as per DSM-IV criteria) other than cigarettes

• coagulopathy

• thrombocytopenia

• use of Coumadin

• intra-cranial hypertension